Regions

FDA clearances

Type 1 diabetes management and CGM integration are now on the table for WellDoc’s BlueStar, a management platform well known for being the first mobile health product to secure reimbursement as a diabetes therapy.
Thanks to a new FDA clearance, the company’s seventh, BlueStar will include integrated glucose level insights related to food, medication and activity that are based on the data from...

Edinburgh, Scotland-based patient monitoring wearable and platform company Current Health (formerly snap40) has cut deals with fellow connected monitor maker VivaLNK and spirometry device company MIR (Medical International Research) to add axillary temperature and spirometry measurement capabilities to its offering.
Enabled by a 510(k) clearance posted by the FDA back in July, these types of...

Earlier this month, Hygieia’s d-Nav Insulin Guidance Service — an app that titrates insulin doses for individual Type 2 diabetes patients, regardless of their regimen type — received 510(k) clearance from the FDA.
The cloud-based service leverages proprietary algorithms, users’ individual blood glucose data and a small team of in-house health professionals to generate and deliver insulin dosage...

This morning medical device company Masimo announced FDA clearance for the measurement of respiration rate from a photoplethysmogram (RRp), so that it may now be used on the MightSat Rx finger pulse oximeter. The latest clearance also means the technology can be used at home by patients.
The new technology will be able to calculate a user’s respiration rate, which is the count of breaths per...

Jerusalem-based Teva Pharmaceuticals’ sensor-packed, app-connected digital inhaler has recently received marketing approval from the US FDA, according to a release from the company. The device will first become available next year through a “small number” of healthcare system pilot partnerships, with a full national launch currently planned for 2020.
Teva’s ProAir Digihaler is indicated for the...

The last few months of 2018 have been fairly active for digital health regulation, with the US FDA roughly a dozen noteworthy devices and consumer health products. But the bigger news out of the agency this quarter comes in the form of its market guidance.
For instance, the very beginning of October saw the release of the Medical Device Cybersecurity Regional Incident Preparedness and Response...

This morning, Omron Healthcare announced that the HeartGuide wristwatch — a wearable oscillometric wrist blood pressure monitor unveiled earlier this year at CES 2018 — has received FDA clearance and will be available at retail on January 9, 2019. The device is currently available for preorder for $499.
The key feature of the product is a flexible synthetic band that is designed to inflate and...

toSense’s CoVa Monitoring System 2, a remote patient monitoring necklace that tracks vitals and cardiac fluids, has received a second FDA clearance.
The new clearance will allow the company to update the software to add a new feature that measures stroke volume and cardiac output to the orginal product. The clearance also lets the device connect to a mobile application that allows medical...

In 2017, MobiHealthNews covered 51 devices that received clearance from the FDA. Along with a handful of diagnostic devices, disease management platforms, and novel monitors, this year boasted a few surprises from the agency, such as the approval of a direct-to-consumer genetic tests for disease risk and a purely digital intervention. The year also hosted its fair share of regulatory news and...

The FDA has been a busy agency these past few months. The second quarter of 2017 has seen a flurry of clearances, many for technologies that continue the trend toward mobile, or even wearable devices. It’s been a good period for those with diabetes, sleep disorders and traumatic injury, not to mention those just looking to maintain and manage their health – with a little digital help, of course....